Following the death of at least one patient, Medtronic is recalling its Valiant Navion thoracic stent graft system, asking healthcare providers to immediately stop using the device.
Medtronic announced the Valiant Navion Thoracic Stent Graft System recall in a press release issued on February 17, following reports of multiple side effects, including one death reported in a Medtronic clinical trial.
The company is calling on doctors to return all unused Valiant Navion thoracic stent graft systems and to immediately stop using the device due to the potential for serious side effects.
The Medtronic recall was initiated due to results from the Valiant Evo Global Clinical Trial, which resulted in three patients in the clinical trial experiencing stent fractures. Two patients had confirmed type IIIb endoleaks, with one dying as a result.
The stent graft is an implantable device used to repair damaged arteries using a tube threaded through the groin and up into the chest. This type of procedure allows the doctors to avoid invasive open-heart surgery.
After the findings of the clinical trial were shared, an independent imaging laboratory reviewed all available images from patients enrolled in the Valiant Evo Global Clinical Trial. The investigation determined seven out of 87 patients had stent ring enlargements beyond the design specifications.
Medtronic is currently conducting a comprehensive technical root cause investigation, including a further review of follow-up clinical trial imaging and commercial complaints.
“There is nothing more important than the safety and well-being of patients,” said Nina Goodheart, senior vice president and president, Structural Heart & Aortic, a part of the Cardiac Vascular Group at Medtronic. “Our decision to implement this voluntary recall is necessary to ensure the utmost patient safety. As our investigation continues, we are committed to timely communication with physicians and regulatory bodies.”
Patients with the thoracic stent graft system should consult with their doctor immediately. Doctors were sent written communication from Medtronic directing them to immediately stop using the graft system and included instructions for returning unused devices.
Doctors should also review all imaging of patients treated with the Valiant Navion thoracic stent graft system and look for stent fractures and type IIIb endoleaks. Doctors should also conduct annual follow-ups with patients.
Healthcare providers should contact Medtronic if imaging findings are observed and notify Medtronic of any adverse events or product safety issues. Medtronic recommends any adverse events should be reported to the FDA’s MedWatch Adverse Event Reporting program.